AZD8075 Single Ascending Dose Study

This study has been terminated.

(After reports of turbidity in urine in 4 of 8 volunteers in the 4th cohort, the study was halted temporarily.)

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00787072

First received: November 6, 2008

Last updated: November 30, 2010

Last verified: November 2010

Purpose

The aim of this study is to assess the safety, tolerability and pharmacokinetics of single ascending oral doses of AZD8075 in healthy male volunteers

Condition	Intervention	Phase
Healthy Volunteers	Drug: AZD8075 Drug: Placebo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Basic Science
Official Title:	A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of AZD8075 in Healthy Male Volunteers

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab) [ Time Frame: Frequent sampling occasions during study days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

PK variables [ Time Frame: Frequent sampling occasions during study days ] [ Designated as safety issue: No ]

Estimated Enrollment:	72
Study Start Date:	October 2008
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: AZD8075 Single dose, the starting dose will be 7 mg, oral suspension, with up to 8 dose escalations not exceeding AstraZeneca pre-defined upper exposure limits.
Placebo Comparator: 2	Drug: Placebo Oral suspension

Eligibility

Criteria

Inclusion Criteria:

Provision of signed, written and dated informed consent prior to any study specific procedures.
Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg.
Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for >6 months prior to study start.

Exclusion Criteria:

Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject's ability to participate
Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs (vital signs (ie, supine BP and pulse) or ECG at baseline, which, in the opinion of the investigator, may put the subject at risk.
Participation in another investigational drug study within 3 months before Visit 2 or participation in a method development study (no drug) 1 month prior to Visit 2

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00787072

Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Eva Pettersson	AstraZeneca R&D, Lund, Sweden
Principal Investigator:	Wolfgang Kühn	Quintiles, Uppsala, Sweden

More Information

No publications provided

Responsible Party:	Christer Hultquist, Medical Science Director, AstraZeneca R&D Lund, Sweden
ClinicalTrials.gov Identifier:	NCT00787072 History of Changes
Other Study ID Numbers:	D3801C00001
Study First Received:	November 6, 2008
Last Updated:	November 30, 2010
Health Authority:	Sweden: Medical Products Agency

ClinicalTrials.gov processed this record on May 22, 2013